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The International Regulatory Framework for the Use of GMOs and Products Thereof as Food Aid

Published online by Cambridge University Press:  22 March 2018

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Footnotes

*

Associate Professor of EU Law and Advanced International Law, University of Perugia; e-mail: simone.vezzani@unipg.it. This paper was made possible by funds provided by the Law Department of the University of Perugia (“Ricerca di base 2015”) for the project “Subjective legal positions between (domestic) uncertainties and search for (supranational) effective protection”, coordinated by Professor Luisa Cassetti. I would like to thank the anonymous referees for their valuable comments. The usual disclaimer applies. All the websites quoted in the paper were last visited on 20 September 2017.

References

1 Zerbe, N, “Feeding the Famine? American Food Aid and the GMO Debate in Southern Africa” (2004) 29 Food Policy 593 CrossRefGoogle Scholar.

It should be noted in this context that, apart from providing GM food aid, the United States Agency for International Development has been sharply criticised for supporting non-governmental organisations which promote the cultivation of GMOs in the African continent ( Carayol, R, “Bataille autour des semences transgéniques en Afrique”, Le Monde Diplomatique, September 2017, 11)Google Scholar.

2 See section VI, below, especially notes 46–49.

3 Gonzales, CG, “Genetically Modified Organisms and Justice: The International Environmental Justice Implications of Biotechnology” (2007) 19 Georgetown International Environmental Law Review 583 Google Scholar.

4 See EFSA, “Assessment of Potential Impacts of GM Plants on Non-Target Organisms”, 21 October 2010, at <www.efsa.europa.eu/en/efsajournal/pub/1877>.

5 On the notion of gene pollution see Vezzani, S, “Quale riparazione per il danno da ‘bioinquinamento’? Riflessioni in margine alle recenti legislazioni europee in tema di GM crops liability ” (2006) 8 Diritto pubblico comparato ed europeo 1384 Google Scholar.

6 Gonzales, supra note 3; Footer, M, “Agricultural Biotechnology, Food Security and Human Rights” in F Francioni and T Scovazzi (eds), Biotechnology and International Law (Oxford, Hart Publishing, 2006) 257 Google Scholar.

7 Vezzani, S, “Le risorse fitogenetiche per l’alimentazione e l’agricoltura nel dibattito sui global commons ” (2013) 31 Rivista critica del diritto privato 433 Google Scholar.

8 A case in point is provided by the fall in production and quality of cotton crops in Burkina Faso, after the introduction of Monsanto’s cotton Bt (Carayol, supra note 1, 10–11).

9 See Chiarabolli, A, “Coexistence of Genetically Modified Crops with Conventional and Organic Agriculture in the European Union” (2011) 11 Global Jurist ISSN (Online) 1934-2640 CrossRefGoogle Scholar. For some estimates concerning costs for implementing technical segregation measures see Institute for Prospective Technological Studies, “New Case Studies on the Coexistence of GM and non-GM Crops in European Agriculture (January 2006)”, at <www.jrc.es/home/pages/eur22102enfinal.pdf>.

10 On the global status of GM crops see <www.isaaa.org>.

11 Clapp, J, “The Political Economy of Food Aid in an Era of Agricultural Biotechnology”, in C Counihan and P Van Esterik (eds), Food and Culture. A Reader (New York, Routledge, 2013) 531, 534 Google Scholar.

12 ibid 535; AC Lewin, “Zambia and Genetically Modified Food Aid” (2007), at <cip.cornell.edu/dns.gfs/1200428165>.

13 C Zvauya, “Zimbabwe Says It Won’t Accept GMO Corn for Drought Relief”, 10 February 2016, at <www.bloomberg.com/news/articles/2016-02-10/zimbabwe-says-it-won-t-accept-gmo-corn-for-drought-relief>.

14 Quoted in Clapp, J, “WTO Agricultural Trade Battles and Food Aid” (2004) 25 Third World Quarterly 1439, 1447 CrossRefGoogle Scholar.

15 Luce, E, “India Rejects US Shipment of GM Food”, Financial Times, 2 January 2003, at <www.iatp.org/news/india-rejects-us-shipment-of-gm-food>Google Scholar.

16 ibid.

17 For a general overview see Keetch, DP et al (eds), Biosafety in Africa: Experiences and Best Practices (East Lansing, Michigan State University Press, 2014)Google Scholar.

18 S Zarrilli, “International Trade in GMOs: Legal Frameworks and Developing Country Concerns”, UN Doc UNCTAD/DITC/TNCD/2004/1, 8 November 2004, 9–10.

19 Waithaka, M et al, “Progress and Challenges for Implementation of the Common Market for Eastern and Southern Africa Policy on Biotechnology and Biosafety” (2015) 3 Frontiers in Bioengineering and Biotechnology 1 CrossRefGoogle ScholarPubMed.

20 Said countries also include Nicaragua and Bolivia (Clapp, supra note 11).

21 S Zarrilli, “International Trade in GMOs and GM Products: National and Multilateral Legal Frameworks, UNCTAD Policy Issues in International Trade and Commodities” (2005) Study Series No 29, at <www.fao.org/fileadmin/user_upload/gmfp/resources/UNITED%20NATIONS%20CONFERENCE%20ON%20TRADE%20AND%20DEVELOPMENT.en.pdf>; Clapp, supra notes 11 and 14.

22 In the same year, a shipment of cereals from the WFP was temporarily held up by the Sudanese authorities, on suspicion that the donated grains were genetically modified, before being finally released ( Moola, S and Munnik, V Google Scholar, GMOs in Africa: Food and Agriculture. Status Report 2007 (The African Centre for Biosafety, 2007) 14).

23 Endicott, M, “The Cartagena Protocol and the Regulation of G.M. Food Aid” in M-C Cordonier Segger, F Perron-Welch and C Frison (eds), Legal Aspects of Implementing the Cartagena Protocol on Biosafety (Cambridge, Cambridge University Press, 2013) 502, 503504 Google Scholar; K Elliott and J Madan, “Can GMOs Deliver for Africa?” (2016) CGD Policy Paper No 80. The link between the food aid crisis and the WTO Biotech Products dispute was also emphasised by Robert Zoellick. According to the (then) US Trade Representative, “the EU moratorium has sent a devastating signal to developing countries that stand to benefit most from innovative agricultural technologies. This dangerous effect of the EU’s moratorium became evident last fall, when some famine-striken African countries refused U.S. food aid because of fabricated fears – stoked by irresponsible rhetoric – about food safety”: RB Zoellick, “United States v. European Union”, The Wall Street Journal, 21 May 2003, at <https://ustr.gov/archive/Document_Library/Op-eds/2003/United_States_v_European_Union.html>.

24 Nordlee, JA et al, “Identification of a Brazil-Nut Allergen in Transgenic Soybeans” (1996) 334 New England Journal of Medicine 688 CrossRefGoogle ScholarPubMed.

25 For instance, as concerns GMOs authorised for food use in the EU, no risk for human health has been detected by EFSA.

26 Hilbeck, A et al, “No Scientific Consensus on GMO Safety” (2015) 27 Environmental Sciences Europe 1 CrossRefGoogle Scholar, at <www.enveurope.com/content/pdf/s12302-014-0034-1.pdf>.

27 Bodiguel, L and Cardwell, M (eds), The Regulation of Genetically Modified Organisms: Comparative Approaches (Oxford, Oxford University Press, 2010)CrossRefGoogle Scholar.

28 Tegner Anker, H and Grossman, MR, “Authorization of Genetically Modified Organisms: Precaution in US and EC Law” (2009) 4 European Food and Feed Law Review 3 Google Scholar; Findley, T, “Genetically Engineered Crops. How the Courts Dismantled the Doctrine of Substantial Equivalence” (2016) 27 Duke Environmental Law and Policy Forum 119 Google Scholar.

29 ECJ, Case C-157/96, R v Ministry of Agriculture, Fisheries and Food [1998] ECR I-2265, at para 63. On the precautionary principle in EU food law see A Alemanno, Trade in Food: Regulatory and Judicial Approaches in the EC and the WTO (London, Cameron May, 2007) 105–160 (for a comparison between the EU and the US approach see ibid 216–223).

30 See Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety [2002] OJ L31/1, Art 7. See also ECJ, Case C-111/16, Fidenato, judgment of 13 September 2017, not yet published, para 46.

31 See Directive (EC) No 2001/18 of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC [2001] OJ L106/1; Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [2003] OJ L268/1; Regulation (EC) 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC [2003] OJ L268/24. For more on the EU regulation on GMOs see inter multos Lee, M, EU Regulation of GMOs: Law, Decision-making and New Technology (Cheltenham, Edward Elgar, 2008)CrossRefGoogle Scholar; Sirsi, E, “GM Food and Feed” in L Costato and F Albissini (eds), European and Global Food Law (Padova, Cedam and Wolters Kluwer, 2016) 425 Google Scholar; Bevilacqua, D, “La regolazione pubblica degli OGM tra tecnica e precauzione” (2016) 34 Rivista critica del diritto privato 275 Google Scholar.

32 EFSA has also developed some guidelines concerning the toxicological assessment and assessment of potential allergenicity of GMOs: “Guidance for Risk Assessment of Food and Feed from GM Plants” (2011); “Guidance on Allergenicity Assessment of Genetically Modified Plants” (2017); see also EFSA, “Guidance on the Environmental Risk Assessment of Genetically Modified Plants” (2010). All these documents can be read at <www.efsa.europa.eu/en/applications/gmo/regulationsandguidance>.

33 Regulation No 1829/2003, supra note 31, Art 7.

34 See Kritikos, M, “Traditional Risk Analysis and Release of GMOs into the European Union: Space for Non-Scientific Factors?” (2009) 34 European Law Review 405 Google Scholar; Petetin, L, “The Precautionary Principle and Non-scientific Factors in the Regulation of Biotech Foods” (2017) 8 European Journal of Risk Regulation 106 Google Scholar.

35 Directive (EU) 2015/412 of 11 March 2015 amending Directive 2001/18/EC as regards the possibility for Member States to restrict or prohibit the cultivation of genetically modified organisms (GMOs) in their territory [2015] OJ L68/1, on which see Poli, S, “The Reform of the EU Legislation on GMOs: A Journey to an Unknown Destination?” (2015) 6 European Journal of Risk Regulation 559 CrossRefGoogle Scholar; Sirsi, E, “Coexistence: a New Perspective, a New Field” (2016) 8 Agriculture and Agricultural Science Procedia 449 Google Scholar; Winter, G, “Cultivation Restrictions for Genetically Modified Plants. On Variety of Risk Governance in European and International Trade Law” (2016) 7 European Journal of Risk Regulation 120 Google Scholar.

36 Doc CAC/GL 45-2003, with Annexes adopted in 2008 and amended in 2011. The Guidelines only deal with the safety and nutritional aspects of biotechnologies. Although they do not expressly embody the precautionary principle, they recognise that unintended and unexpected effects may occur due to the introduction of transgenes and are based on the principle of pre-market approval and pre-market safety assessment.

37 Convention on Biological Diversity, opened for signature at the Earth Summit in Rio de Janeiro on 5 June 1992 and entered into force on 29 December 1993, 31 International Legal Materials 818 (1992), Art 8(g).

38 Convention on Access to Information, Public Participation in Decision-Making and Access to Justice in Environmental Matters (Aarhus, 25 June 1998), 38 International Legal Materials 517 (1999), Art 6(11): “Each Party shall, within the framework of its national law, apply, to the extent feasible and appropriate, provisions of this article to decisions on whether to permit the deliberate release of genetically modified organisms into the environment”. In 2005, Parties to the Aarhus Convention adopted an amendment to the Convention detailing obligations on public participation in GMO decisions, which however has not yet reached the number of ratifications necessary to enter into force (Decision II/1, adopted at the second meeting of the Parties held on 25–27 May 2005).

39 Cartagena Protocol on Biosafety to the Convention on Biological Diversity adopted on 29 January 2000, 39 International Legal Materials 1027 (2000). The Protocol entered into force on 23 September 2003 and so far (September 2017) has been ratified by 171 Parties. See Stoll, P-T, “Controlling the Risks of Genetically Modified Organisms: the Cartagena Protocol on Biosafety and the SPS Agreement” (1999) 10 Yearbook of International Environmental Law 82 CrossRefGoogle Scholar; Pavoni, R, “Assessing and Managing Biotechnology Risk under the Cartagena Protocol on Biosafety” (2000) 10 Italian Yearbook of International Law 113 Google Scholar.

40 L Li Ching, The Cartagena Protocol on Biosafety and Food Aid (2004), Third World Network, Doc.TWN/Biosafety/2004/I; Endicott, supra note 23, 505–508.

41 See, COP-MOP Decision BS-I/6 and other subsequent decisions on the same topic.

42 A Telesetsky, Introductory Note to the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress (2011) 50 ILM 105, 107.

43 UNEP/CBD/BS/COP-MOP/5/17, at para 133.

44 O De Schutter, “Integrating the Right to Adequate Food in Development Co-operation” (2009), at <www.srfood.org/images/stories/pdf/otherdocuments/8-srrtfdevelopmentfoodaid-1-09.pdf>. The said remedies might include judicial remedies, quasi-judicial monitoring systems and other procedures of dispute settlement and prevention.

45 Institute of International Law, “Resolution on Humanitarian Assistance” (Bruges session), Resolution 2 September 2003, at <www.ifrc.org/Docs/idrl/I318EN.pdf>, Art IV(2).

46 ibid, Arts VIII and VII. For a discussion on the point see Helton, AC, “The Legality of Providing Humanitarian Assistance without the Consent of the Sovereign” (1992) 4 International Journal of Refugee Law 373 CrossRefGoogle Scholar; Luopajärvi, K, “Is there an Obligation on States to Accept International Humanitarian Assistance to Internally Displaced Persons under International Law?” (2003) 15 International Journal of Refugee Law 678 Google Scholar.

47 International Law Commission, “Draft Articles on the Protection of Persons in the Event of Disasters, with Commentaries”, adopted by the International Law Commission at its sixty-eighth session, in 2016, and submitted to the General Assembly as a part of the Commission’s report covering the work of that session (A/71/10), at <http://legal.un.org/docs/?path=../ilc/texts/instruments/english/commentaries/6_3_2016.pdf&lang=EF>, para 48.

48 According to many observers, an example of unreasonable refusal of food assistance is provided by the conduct of the Government of Myanmar during the food crisis caused by the Nargis cyclone in 2008, where foreign humanitarian operators were not allowed to enter the country for a long time. A very debated issue is also whether the so-called “responsibility to protect”, which has emerged in UN Security Council practice, implies a duty for donor States to provide food aid when certain specific conditions are met: Ford, S, “Is the Failure to Respond Appropriately to a Natural Disaster a Crime Against Humanity? The Responsibility to Protect and Individual Criminal Responsibility in the Aftermath of Cyclone Nargis” (2010) 38 Denver Journal of International Law and Policy 227 Google Scholar.

49 L Cotula and M Vidar, “The Right to Adequate Food in Emergencies” (2002) FAO Legislative Study No 77, at <www.fao.org/docrep/005/Y4430E/y4430e04.htm#bm4.4>. On this point see, more in general, S Hutter, Starvation as a Weapon. Domestic Policies of Deliberate Starvation as a Means to an End under International Law (Leiden, Brill Nijhoff, 2015).

50 Commentary to Art 14 of the ILC’s Draft Articles, supra note 47, para 9.

51 Committee on Economic, Social and Cultural Rights, General Comment No 12 on the right to adequate food (Art 11), 12 May 1999, UN Doc E/C.12/1999/5. For an analysis of recent trends concerning the protection of the right to food in international law see Chiussi, L, “Food for Thought on the Right to Food” (2015) 70 La Comunità internazionale 355 Google Scholar.

52 See the UN Draft Declaration on the Rights of Peasants and Other People Working in Rural Areas Presented by the Chair-Rapporteur of the Working Group, UN Doc A/HRC/WG.15/4/2, 6 March 2017, at <https://documents-dds-ny.un.org/doc/UNDOC/GEN/G17/051/60/PDF/G1705160.pdf?OpenElement>.

53 See supra note 34.

54 Food Assistance Convention (London, 25 April 2012), depositary notification C.N.215.2012, at <https://treaties.un.org/doc/source/signature/2012/CTC_XIX-48.pdf>.

55 La Chimia, A, “Food Security and the Right to Food: Finding Balance in the 2012 Food Assistance Convention” (2016) 65 International and Comparative Law Quarterly 99, 134 CrossRefGoogle Scholar.

56 Acconci, P, “Food Security within the Framework of International Assistance for Development: Working towards Rural Sustainability for the Realization of the Right to Food” in M Fitzmaurice et al (eds), The Challenges of Environmental Protection and Sustainable Development from Rio to Rio+20 and Beyond (Leiden, Brill Nijhoff, 2014) 177 Google Scholar; Cuq, M, “La Convention de 2012 relative à l’assistance alimentaire: une avancée pour l’aide et le développement en faveur d’un accès à une alimentation adéquate?” in F Collart Dutilleul and T Bréger (eds), Penser une démocratie alimentaire (Vol. 2) (San José, INIDA, 2014) 413 Google Scholar.

57 La Chimia, supra note 55, 134.

59 Donor States’ obligation to respect the principle of ownership in development cooperation policies has been particularly emphasised by the former Special Rapporteur on the Right to Food, Olivier De Schutter, supra note 44; id, “The Transformative Potential of the Right to Food”, UN Doc A/HRC/25/57, 24 January 2014, 28.

60 La Chimia, supra note 55, 118.

61 See inter alia Safrin, S, “Treaties in Collision? The Biosafety Protocol and the World Trade Organization Agreements” (2002) 98 American Journal of International Law 606 CrossRefGoogle Scholar; Vecchione, E, “Is It Possible To Provide Evidence of Insufficient Evidence? The Precautionary Principle and the WTO” (2012) 13 Chicago Journal of International Law 153 Google Scholar.

62 European Communities – Measures Affecting the Approval and Marketing of Biotech Products, WT/DS291/R, WT/DS292/R, WT/DS293/R, Add. 1 to Add.9, and Corr. 1, panel report adopted on 21 November 2006, DSR 2006. III-VIII. For analysis see S Poli, La controversia sugli organismi geneticamente modificati tra obblighi OMC e competenza comunitaria (Napoli, Editoriale scientifica, 2008).

63 Wirth, DA, “The World Trade Organization Dispute Concerning Genetically Modified Organisms: Precaution Meets International Trade Law” (2013) 37 Vermont Law Review 1153 Google Scholar.

64 Art 3 reads as follows: “[n]othing in this Convention shall derogate from any existing or future WTO obligations applicable between Parties. In case of conflict between such obligations and this Convention, the former shall prevail. Nothing in this Convention will prejudice the positions that a Party may adopt in any negotiations in the WTO”. For a comment on this point see La Chimia, supra note 55, 129–133.

65 See Clapp, supra note 14; La Chimia, A and Arrowsmith, S, “Addressing Ties Aid: Towards a more Development-Oriented WTO?” (2009) 12 Journal of International Economic Law 707 CrossRefGoogle Scholar.

66 WTO Ministerial Decision of 19 December 2015 on Export Competition (WT/MIN(15)/45) paras 22–32.

67 For instance, as concerns food donation contemplated by the Italian “Good Samaritan Act”, see Strambi, G, “Limiti e regole nella distribuzione delle eccedenze alimentari” in A Di Lauro (ed), Nutri Dialogo. Il Diritto incontra le altre Scienze su Agricoltura, Alimentazione, Ambiente (Pisa, Edizioni ETS, 2015) 35 Google Scholar.

68 “United Nations Statement Regarding the Use of GM Food as Food Aid in Southern Africa”, 23 August 2002, at <www.fao.org/english/newsroom/news/2002/8660-en.html>.

69 WFP/EB.1/2004/10-C, 11 February 2004. The WFP Executive Board took note of this document (see 2004/EBN.1/25).

70 ibid.

71 Humanitarian Charter and Minimum Standards in Humanitarian Response (The Sphere Project, 2011) 207.

72 Regulation (EC) No 1946/2003 on Transboundary Movements of GMO of 5 November 2003 [2003] OJ L287/1.

73 European Commission, DG ECHO Thematic Policy Documents, “Humanitarian Food Assistance: From Food Aid to Food Assistance”, November 2013, at <ec.europa.eu/echo/files/policies/food_assistance/them_policy_doc_foodassistance_en.pdf>, 26.

74 USDA, “Notice to U.S. Food Aid Program Partners. Guidance for Meeting Documentation Requirements for Shipments of LMO’s for Food, Feed, or for Processing Under the Cartagena Protocol on Biosafety”, at <www.google.it/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0ahUKEwjwsfPS3f7TAhUGmBoKHek9DnkQFggjMAA&url=http%3A%2F%2Fcdn.biodiversidadla.org%2Fcontent%2Fdownload%2F3732%2F11121%2Fversion%2F1%2Ffile%2FUSDA.pdf&usg=AFQjCNHuA3hg0vD4rODs-9MEvbtIaj9JPg&sig2=Hd-ke4BLLP1AFyvkGee3Lw>.

75 Act Alliance, Policy Paper on Genetically Modified organisms (GMOs) in Emergency Operations, 27–28 June 2006, at <http://reliefweb.int/sites/reliefweb.int/files/resources/5DCBF84FB7117D19C12571A0002D2FC8-act-gen-june28.pdf>.

76 Mousseau, F, Food Aid or Food Sovereignty? Ending World Hunger in Our Time (The Oakland Institute, 2005), available at <www.oaklandinstitute.org/sites/oaklandinstitute.org/files/fasr.pdf>Google Scholar; Cataldi, G and Serra, G, “Tied Development Aid: A Study on Some Major Legal Issues” (2010) 20 Italian Yearbook of International Law 219 Google Scholar.

77 “Amid Humanitarian Funding Gap, 20 Million People across Africa, Yemen at Risk of Starvation, Emergency Relief Chief Warns Security Council”, UN press release, 10 March 2017, available at <www.un.org/press/en/2017/sc12748.doc.htm>.

78 “WFP Policy on Donations of Food Derived from Biotechnologies (GM/Biotech Foods)”, WFP/EB.3/2002/4-C, 14 October 2002, para 18.